Pharvaris Announces $66 Million Series B Financing to Advance the Clinical Development of an Oral Therapy for Hereditary Angioedema

Pharmavaris获6600万美元B轮融资,加快遗传性血管水肿口服疗法临床开发

2019-09-11 10:00:55 BioSpace

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Pharvaris has initiated its first-in-human clinical trial of PHA121 Series B participants led by Foresite Capital with additional new investors Bain Capital Life Sciences, venBio Partners, and Venrock Partners Pharvaris B.V., a clinical-stage company focused on the discovery and development of novel oral B2-receptor antagonists for the treatment of hereditary angioedema (HAE) and other B2-receptor-mediated indications, has completed a $66 million Series B financing, led by Foresite Capital together with Bain Capital Life Sciences, venBio Partners, and Venrock Partners, as well as existing investors, LSP, Kurma Partners and Idinvest Partners. In addition, the company announced its entry into clinical development with the initiation of a Phase 1 study of its lead compound, PHA121, in healthy volunteers. "This financing and our outstanding syndicate of investors positions Pharvaris as a clinical leader for the development of oral treatments for patients with HAE," said Berndt Modig, Chief Executive Officer and co-founder of Pharvaris. "Our experienced team is capitalizing on its deep knowledge of drug development and HAE as we progress in the clinic with PHA121, a new chemical entity targeting the same mechanism as icatibant, a leading therapy for the treatment of HAE attacks. The demands for less invasive routes of drug administration, more convenient dosing regimens, and additional treatment options support the development of an oral therapy to improve the quality of life of patients with HAE." The proceeds from the Series B financing will enable Pharvaris to expedite the clinical development of PHA121. The first subjects have been dosed in a Phase 1, randomized, double-blind, placebo-controlled, single-ascending-dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PHA121 in healthy subjects. A multiple-ascending-dose study is anticipated to start in early 2020. In preclinical studies, PHA121 demonstrates oral bioavailability, selective antagonism of the B2 receptor, and potent and rapid activity in bradykinin-mediated disease models. Jochen Knolle, Ph.D., Chief Scientific Officer and co-founder of Pharvaris, added, "Patients with HAE are eager for effective oral therapies. The development of a novel, oral B2-receptor antagonist could represent a new standard of care for the treatment and prevention of HAE and other B2-receptor-mediated conditions. This first-in-human Phase 1 study is expected to yield important safety and tolerability data. In addition, we expect to demonstrate pharmacodynamics for blocking bradykinin signaling, which will inform the design of subsequent clinical trials." Dr. Knolle is an inventor of icatibant and, as Chief Scientific Officer and Head of R&D at Jerini AG, was instrumental in the development and first approval of icatibant for treatment of HAE. Brett Zbar, M.D., Managing Director of Foresite Capital, and Richard Gaster, M.D., Ph.D., Principal at venBio Partners, will join Pharvaris' board of directors. Ricky Sun, Ph.D., Partner at Bain Capital Life Sciences, will join the board as an observer. About Hereditary Angioedema Hereditary angioedema is a rare and potentially life-threatening genetic condition with incidence between 1 in 10,000 and 1 in 50,000 people according to HAE International (HAEi), the global umbrella organization for the world's HAE patient groups. HAE patients are susceptible to sudden and prolonged attacks of edema in the hands, feet, face, gastrointestinal tract, and airways, resulting in severe swelling and pain, airway blockage, and nausea. Current therapies are limited by invasive routes of drug administration (injection or infusion), inconvenient dosing regimens, or undesired side effects. About Pharvaris Pharvaris is a clinical-stage company focused on bringing oral B2-receptor antagonists to patients. By targeting this clinically proven therapeutic target with novel small molecules, we are progressing new alternatives to injected therapies for all sub-types of HAE and other B2-receptor-mediated indications. The company brings together executives with a breadth of expertise across pharmaceutical development and rare disorders, including HAE. For more information, visit https://pharvaris.com/. Investor Contact Chad Rubin, Solebury Trout crubin@soleburytrout.com Media Contact Maggie Beller, Russo Partners, LLC maggie.beller@russopartnersllc.com +1-646-942-5631 multimedia:http://www.prnewswire.com/news-releases/pharvaris-announces-66-million-series-b-financing-to-advance-the-clinical-development-of-an-oral-therapy-for-hereditary-angioedema-300914502.html
Pharmavaris 已经启动了 PHA121的首个人体临床试验 B 系列参与者由 Foresite Capital 和其他新投资者 Bain Capital Life Sciences 、 Venbio Partners 和 Venrock Partners 领衔 Pharvaris,一家临床阶段公司,专注于发现和开发新型口服 B2受体拮抗剂,用于治疗遗传性血管水肿( HAE )和其他 B2受体介导的适应症,已经完成了6600万美元的 B 系列融资,由 Foresite Capital 和 Bain Capital Life Sciences 、 venBio Partners 和 Venrock Partners 以及现有投资者 LSP 、 Kurma Partners 和 Idinvest Partners 共同领导。此外,公司宣布在健康志愿者中启动其先导化合物 PHA121的第1阶段研究,进入临床开发阶段。 “这笔融资和我们杰出的投资者财团将 Phavaris 定位为临床领导者,为 HAE 患者开发口腔治疗,”首席执行官兼 Phavaris 联合创始人 Berndt Modig 说。「我们的经验丰富的队伍正利用其对药物发展及港机工程的深入认识,与 PHA121在临床上取得进展。 PHA121是一个新的化学实体,其目标是与 icatibant 相同的机制,是治疗港机工程攻击的领先疗法。对较少侵入性给药途径、更方便的给药方案和额外的治疗方案的需求支持了口腔治疗的发展,以改善患者的生活质量。 B 系列融资的收益将使 Pharmavaris 加快 PHA121的临床开发。首批受试者已在第1期、随机、双盲、安慰剂对照、单升剂量研究中进行剂量测定,以评价 PHA121在健康受试者中的安全性、耐受性、药代动力学和药效学。多剂量递增研究预计将于2020年初开始。在临床前研究中, PHA121显示了口服生物利用度、 B2受体的选择性拮抗,以及在缓激肽介导的疾病模型中的强效和快速活性。 JochenKnolle 博士,首席科学官和 Pharmavaris 的联合创始人,补充说,“ HAE 患者渴望有效的口服疗法。开发一种新型的口服 B2受体拮抗剂可以代表一种新的护理标准,用于治疗和预防 HAE 和其他 B2受体介导的条件。这第一阶段在人类第一阶段的研究预计将产生重要的安全和耐受性数据。此外,我们期望展示阻断缓激肽信号传导的药效学,这将为后续临床试验的设计提供参考。”Knolle 博士是一位冒药的发明者,作为杰里尼股份公司的首席科学官员和研发负责人,对开发和首次批准冒药治疗港机工程起到了重要作用。 Brett Zbar , M.D ., Foresite Capital 董事总经理, Richard Gaster ,医学博士(M.D.)., Ph.D ., VenBio Partners 的负责人,将加入 Phavaris 的董事会。贝恩资本生命科学( BainCapitalLifeSciences )合伙人孙瑞奇( RickySun )博士将以观察员身份加入董事会。 关于遗传性血管水肿 根据全球 HAE 患者群体保护组织 HAE International (港机工程国际)的数据,遗传性血管性水肿是一种罕见且可能危及生命的遗传病,发病率在1万至5万人之间。HAE 患者易受手、脚、面部、胃肠道和气道突然和长期的水肿攻击,导致严重的肿胀和疼痛、气道阻塞和恶心。目前的治疗方法受到药物给药(注射或输液)的侵袭性途径、不方便的给药方案或不希望的副作用的限制。 关于 Pharmavaris Pharmavaris 是一家专注于为患者带来口服 B2受体拮抗剂的临床阶段公司。通过将这一临床证实的治疗靶点与新的小分子靶向,我们正在开发新的替代注射疗法的所有亚类的 HAE 和其他 B2受体介导的适应症。该公司汇集了在医药开发和罕见疾病领域拥有广泛专业知识的管理人员,包括港机工程。有关更多信息,请访问 https://pharmivals 。com /。 投资者联系方式 Chad Rubin , Solebury Trout crubin @ soleburytroup.com 媒体联系人 Maggie Beller , Russo Partners , LLC 麦琪。beller @ russopartnersllc.com +1-646-942-5631 多媒体: http://www.prnewswire.com/news-releases/pharmavaris-announcement-announcement-300914502。html

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